The Food and Drug Administration (FDA) Accelerated Approval Program was created in 1992 to considerably speed up the ability to bring certain new drugs to market. Further research to be revealed in upcoming issues of the INFORMS journal Manufacturing & Service Operations Management shows numerous drug producers are failing to finish the approval course of, meaning a significant number of drugs on the market will not be but approved.
Part of the program’s requirement is that manufacturers should comprehensive post-market research to show the effectiveness of each drug that has been pre-approved under this initiative. Only then can these drugs be converted to full, common approval.
However, according to this newly revealed analysis analyzing publicly available data from 2014 to 2018, these studies are not being completed as promised. From 1992 to 2008, 36% of put up-market research had not been completed, and 50% of the uncompleted research took on average of 5 years to even begin.
FDA regulators are facing challenges to determine and enforce deadlines due to unbalanced information and moral hazard. They must optimize the tradeoff between offering public access to potentially life-saving drugs and mitigating public health risks from ineffective medicine.
In summary, this new research provides valuable insights to regulators on granting pre-approval of a drug under the FDA’s Accelerated Approval Program. If the enforceability of a given drug is expected to be low, then regulators could consider requiring a higher success probability before proceeding with conditional approval.